Saccharomyces boulardii is a particular strain of the yeast Saccharomyces cerevisiae, also referred to as Saccharomyces cerevisae var. boulardii, which is mainly indicated as a supplement to rehydration for the treatment of diarrhea.
Its usefulness has notably been established in the treatment of acute diarrhea due to infection in children and adults (Villarruel et al. (2007) Acta Paediatr 96:538-541; Szajewska et al. (2007) Aliment Pharmacol Ther 25:257-264), in the prevention of antibiotic-associated diarrhea in children and adults (Surawicz et al. (1989) Gastroenterology 96:981-988; Kotowska et al. (2005) Aliment Pharmacol Ther 21:583-590), in the prevention of Clostridium difficile diarrhea and colitis (Surawicz et al. (2000) Clin Infect Dis 31:1012-1017), in the prophylaxis of traveler's diarrhea (McFarland (2007) Travel Med Infect Dis 5:97-105), as well as in the prophylaxis of diarrhea in tube-fed patients (Schlotterer et al. (1987) Nutrition Clinique et Métabolisme 1:31-34; Bleichner et al. (1997) Intensive Care Medicine 23:517-523). Besides, S. boulardii has also been reported to be useful for managing irritable bowel syndrome (IBS) and inflammatory bowel diseases (IBD).
Safety and adverse event data collected during clinical trials, when patients are closely monitored for adverse effects possibly related to the investigational treatment, has documented a remarkable safety profile of S. boulardii. However, infrequent cases of S. boulardii fungemia have been occasionally reported, essentially in individuals which have central venous catheters. As such, it has sometimes been recommended not to give S. boulardii to immunocompromised patients or those with central catheters to reduce this risk (McFarland (2010) World J Gastroenterol 16:2202-2222; Santino et al. (2014) Int J Immunopathol Pharmacol 27:143-6).
However, these individuals could benefit from S. boulardii treatment, as it has notably been shown that S. boulardii was useful for managing pathologies such as HIV-associated diarrhea as well as enteral nutrition-related diarrhea that may arise in immunocompromised patients.
Accordingly, it is an object of the invention to reinforce the safety of S. boulardii usage by preventing undesirable effects.